Drive assembly for use in a robotic control and guidance system

ABSTRACT

A drive assembly for use in a robotic control and guidance system comprises a cartridge having an outer housing and a rotatable medical device assembly disposed therein. The rotatable assembly includes a medical device having proximal and distal ends, and a housing having first and second ends, and a longitudinal axis extending therethrough. The proximal end of the medical device is disposed within the housing, and the housing further comprises an opening through which the medical device extends outwardly from said housing. The rotatable assembly further comprises a drive interface coupled with the housing. The drive assembly further comprises a manipulation base comprising a mounting plate onto which the cartridge is removably attached, and a drive system mounted to the mounting plate. The drive system is configured to operatively engage the cartridge drive interface and to impart rotational movement onto the rotatable assembly through the drive interface.

BACKGROUND OF THE INVENTION

a. Field of the Invention

The present disclosure relates generally to a robotic control andguidance system (RCGS) for one or more medical devices. Moreparticularly, the present disclosure relates to a drive assembly for usein a RCGS that comprises, for example, a manipulation base and a medicaldevice cartridge for a medical device, such as, for example, a spiralmapping catheter.

b. Background Art

Electrophysiology (EP) catheters are used in a variety of diagnosticand/or therapeutic medical procedures to correct conditions such asatrial arrhythmia, including for example, ectopic atrial tachycardia,atrial fibrillation, and atrial flutter. Arrhythmia can create a varietyof dangerous conditions including irregular heart rates, loss ofsynchronous atrioventricular contractions and stasis of blood flow whichcan lead to a variety of ailments.

In a typical EP procedure, a physician manipulates a catheter through apatient's vasculature to, for example, a patient's heart. The cathetertypically carries one or more electrodes or sensors that may be used formapping, ablation, diagnosis, and the like. Once at a target tissuesite, the physician commences diagnostic and/or therapeutic procedures.Such procedures require precise control of the catheter duringnavigation, and delivery of therapy, to the target tissue site, whichcan invariably be a function of a user's skill level.

Robotic control and guidance systems (RCGS) for one or more medicaldevices (or robotically controlled medical device guidance systems) areknown to facilitate such precise control. In general, these types ofsystems carry out (as a mechanical surrogate) input commands of aclinician or other end-user to deploy, navigate, and manipulate one ormore medical devices, such as, for example, a catheter and/or anintroducer or sheath for a catheter, or some other elongate medicalinstrument. One exemplary robotic catheter system is described anddepicted in U.S. Patent Publication No. 2009/0247993 entitled “RoboticCatheter System,” the entire disclosure of which is incorporated hereinby reference.

While such systems have proved useful with respect to providing, amongother benefits, precise control as described above, the particular useof an RCGS to perform mapping functions with certain medical devices(e.g., spiral mapping catheters) has proved complicated. This complexityis generally due to the fact that the these medical devices must berotated into pulmonary veins. This presents a number of difficulties orissues. For example, one such issue relates to how a rotary or spiralcatheter having multiple control actions (i.e., three-axis motiontranslation, rotation, and the occlusion of the loop at the distal endof the device) and multiple sensors (e.g., electrodes), which, in someinstances may number in upwards of twenty-four (24), can be manipulatedwithout excessively complex mechanical or electrical interfacing.

Another issue relating to the use of an RCGS with a rotary or spiralmedical device relates to how to shield the medical device and othercomponents disposed in a sterile field (e.g., the table, drapes, thepatient, etc.) from contaminants, and therefore, maintain sterility,when a non-sterile manipulating system is used.

Accordingly, the inventor herein has recognized a need for apparatus,such as, for example, a drive assembly and the constituent componentsthereof, for use with a RCGS that will minimize and/or eliminate one ormore of the deficiencies in conventional systems.

BRIEF SUMMARY OF THE INVENTION

The present invention is directed to drive assembly for use in a roboticcontrol and guidance system, and the constituent components thereof.

In accordance with one aspect of the invention and the presentteachings, the drive assembly comprises a medical device cartridge and amanipulation base to which the cartridge is removably attached. In anexemplary embodiment, the drive assembly further includes a sterilebarrier disposed between the cartridge and the manipulation base.

The cartridge of the drive assembly comprises an outer housing and arotatable medical device assembly disposed within the outer housing. Therotatable medical device assembly, in turn, comprises an elongatemedical device having a proximal end and a distal end, a housing withinwhich a portion of the medical device is disposed, and a drive interfacecoupled with the housing.

More particularly, the a housing of the rotatable medical deviceincludes a first end, a second end, and a longitudinal axis extendingtherethrough. The proximal end of the elongate medical device isdisposed within the housing, and the housing further comprises anopening disposed in the first end thereof through which the elongatemedical device extends outwardly from the housing in an axial directionrelative to the longitudinal axis of the housing.

The manipulation base of the drive assembly comprises a mounting plateonto which the medical device cartridge is removably attached, and adrive system mounted to the mounting plate. The drive system comprises arotary actuator and is configured to operatively engage the driveinterface of the cartridge and to impart rotational movement onto therotatable medical device assembly through the drive interface. In anexemplary embodiment, a portion of the outer housing of the cartridgecomprises a base plate configured to be attached to the mounting plateof the manipulation base, and that has at least one aperture therein tofacilitate the operative engagement of the drive interface of thecartridge with the drive system of the manipulation base. In anexemplary embodiment, the outer housing is configured to shieldcomponents disposed within the outer housing and/or in a field externalthereto from contaminants.

The mounting plate of the manipulation base has a first side and asecond side, and in an exemplary embodiment, the cartridge of the driveassembly is mounted to the first side, while the drive system of themanipulation base is mounted to the second side.

In an exemplary embodiment, the cartridge of the drive assembly furthercomprises an electrical port disposed in the housing of the rotatablemedical device assembly. The port has a first end that is configured tobe electrically coupled with a lead wire of a sensor associated with theelongate medical device, and a second end external to the housing of therotatable medical device assembly that is configured to be electricallycoupled with a complementary electrical connector. In an exemplaryembodiment, the manipulation base of the drive assembly furthercomprises a commutator mounted on the mounting plate thereof proximatethe cartridge. The commutator has a first electrical connector that maybe electrically coupled to the second end of the port of the cartridge,and a second electrical connector configured for coupling with acomplementary electrical connector of an electrical cable.

In an exemplary embodiment, the drive interface of the cartridge, andthe rotatable medical device assembly thereof, in particular, is a firstdrive interface, and the drive system of the manipulation base is afirst drive assembly. Further, the medical device comprises a steeringwire and the rotatable medical device assembly comprises a controlmember, such as, for example, a slider block, disposed within thehousing thereof and rigidly coupled with the steering wire of themedical device. The control member is configured for translationalmovement relative to the longitudinal axis of the housing. In such anembodiment, the cartridge further comprises a second drive interfacecoupled with the control member, and the manipulation base furthercomprises a second drive system mounted to said mounting plate. Thesecond drive system comprises an electromechanical device and isconfigured to operatively engage the second drive interface of thecartridge and to impart translational movement onto the control memberthrough the second drive interface.

In accordance with another aspect of the invention and the presentteachings, a manipulation base for use with a medical device cartridgein a robotically controlled medical device guidance system is provided.The manipulation base comprises a mounting plate configured to have amedical device cartridge removably attached thereto and defines alongitudinal axis. The manipulation base further comprises a drivesystem mounted to the mounting plate, wherein the drive system comprisesa rotary actuator and is configured to operatively engage a driveinterface of the cartridge and to impart rotational movement onto thedrive interface of the cartridge. The rotary actuator may comprise amotor, and the drive interface may further comprise one of amotor-driven friction interface and a motor-driven gear arrangement.

In an exemplary embodiment, the drive system of the manipulation base isa first drive system, and the drive interface of the cartridge is afirst drive interface. In such an embodiment, the manipulation basefurther comprises a second drive system mounted to the mounting plate.The second drive system comprises an electromechanical device and isconfigured to operatively engage a second drive interface of thecartridge, and to impart translational movement onto the second driveinterface. The electromechanical device may comprise, for example, amotor and one of a motor-driven ball screw and a motor-drive lead screw.Further, the second drive system may comprise a driven member, which inan exemplary embodiment is a drive fork, configured to operativelyengage the second drive interface of the cartridge and to be drive bythe electromechanical device. The driven member may further include aroller disposed therein that is configured to operatively engage thesecond drive interface of the cartridge to facilitate rotation of thesecond drive interface. In an exemplary embodiment, the second drivesystem further comprises a force sensor that is configured formechanically isolated sensing of the force applied by the second drivesystem onto the second drive interface. The force sensor may comprise astrain gauge or a motor current sensor. In an exemplary embodiment, thedriven member of the second drive system is coupled to theelectromechanical device by the force sensor. Further, the manipulationbase may comprise a bearing block associated with the driven member anda bearing rail, wherein the bearing block is configured to travel alongthe bearing rail as the driven member is driven by the electromechanicaldevice.

In an exemplary embodiment, the manipulation base still furthercomprises a commutator mounted on the mounting plate. The commutator hasa first electrical connector configured to be electrically connected toan electrical port of the cartridge to thereby electrically connect thecommutator to at least one sensor of the elongate medical device that iselectrically connected to the electrical port. The commentator furthercomprises a second electrical connector configured for coupling thecommutator with a complementary electrical connector of an electricalcable.

In accordance with another aspect of the invention, a medical devicecartridge for use in a robotically controlled medical device guidancesystem is provided. The cartridge comprises an outer housing and arotatable medical device assembly disposed within the outer housing. Therotatable medical device assembly comprises an elongate medical devicehaving a proximal and a distal end, and in an exemplary embodiment, oneor more steering wires. In an exemplary embodiment, the elongate medicaldevice may further comprise one or more force sensors disposed thereinconfigured to measure, for example, the force applied to the steeringwire(s) thereof. The rotatable medical device assembly further comprisesa housing having a first end, a second end, and a longitudinal axisextending therethrough. The proximal end of the medical device isdisposed within the housing, and the housing comprises an openingdisposed in the first end thereof through which the medical deviceextends outwardly from the housing in an axial direction relative to thelongitudinal axis of the housing. The rotatable assembly furthercomprises a drive interface coupled with the housing and configured tobe operatively engaged with a drive system of a manipulation base toimpart rotational movement onto the rotatable assembly about thelongitudinal axis of the housing.

In an exemplary embodiment, the outer housing of the cartridge comprisesa first portion having an opening therein that is coaxially arrangedwith the opening in the housing of the rotatable assembly such that theelongate medical device extends outwardly from the outer housing of thecartridge. The outer housing may further comprise a second portioncomprising a base plate of the cartridge that is configured to permitthe cartridge to be removably attached to the manipulation base, andthat had at least one aperture therein configured to permit theoperative engagement of the drive interface with the drive system of themanipulation base. In an exemplary embodiment, the outer housing isconfigured to shield components disposed within the outer housing and/orin a field external thereto from contaminants.

In an exemplary, the drive interface of the rotatable medical deviceassembly is configured to be operatively engaged with the drive systemof said manipulation base that is axially-arranged with the rotatablemedical device assembly relative to the longitudinal axis of the housingthereof. In another exemplary embodiment, the drive interface isconfigured to be operatively engaged with the drive system of themanipulation base that is disposed below the rotatable medical deviceassembly (i.e., disposed below the longitudinal axis of the housing ofthe rotatable medical device assembly).

In an exemplary embodiment, the drive interface of the rotatableassembly is a first drive interface configured to be operatively engagedwith a first drive system of the manipulation base. In such anembodiment, the rotatable medical device assembly may further comprise acontrol member, such as, for example, a slider block, disposed with thehousing thereof and rigidly coupled with a steering wire of the medicaldevice. The control member is configured to translational movementrelative to the longitudinal axis of the housing. The rotatable medicaldevice assembly may still further comprise a second drive interfacecoupled with the control member and configured to be operatively engagedwith a second drive system of the manipulation base to imparttranslational movement onto the control member. In an exemplaryembodiment, the housing of the rotatable assembly includes an axiallyextending slot therein, and the control member includes a pin extendingtherefrom in a radial direction relative to the longitudinal axis. Thepin is disposed and configured for travel within the slot in an axialdirection relative to the longitudinal axis, and the second driveinterface is coupled with the pin.

In an exemplary embodiment, the control member of the rotatable medicaldevice assembly is a first control member, and the steering wire coupledthereto is a first steering wire of the medical device. In such anembodiment, the rotatable assembly further comprises a second controlmember, such as, for example, a slider block, disposed within thehousing thereof and rigidly coupled to a second steering wire of themedical device. The second control member is configured fortranslational movement relative to the longitudinal axis of the housing.The rotatable assembly may further comprise a third drive interfacecoupled with the second control member and configured to be operativelyengaged with a third drive system of the manipulation base to imparttranslational movement onto the second control member. In an exemplaryembodiment, the housing of the rotatable assembly includes an axiallyextending slot therein, and the second control member includes a pinextending therefrom in a radial direction relative to the longitudinalaxis. The pin is disposed and configured for travel within the slot inan axial direction relative to the longitudinal axis, and the thirddrive interface is coupled with the pin.

In accordance with yet another aspect of the invention, a rotatablemedical device assembly for use in a medical device cartridge of arobotically controller medical device guidance system is provided. Therotatable assembly comprises an elongate medical device having aproximal and a distal end. The rotatable assembly further comprises ahousing having a first end and a second end, and a longitudinal axisextending therethrough. The proximal end of the medical device isdisposed within the housing, and the housing further comprises anopening disposed in the first end thereof through which the medicaldevice extends outwardly from the housing in an axial direction relativeto the longitudinal axis of the housing.

In an exemplary embodiment, the rotatable assembly further comprises ananchor member disposed within said housing and rigidly coupled with theproximal end of the medical device.

The rotatable housing may further comprise an electrical port disposedwithin the housing. The port comprises a first end and a second end,wherein the first end is configured to be electrically coupled with alead wire of a sensor of the medical device, and the second end isdisposed external to the housing and configured to be electricallycoupled with a complementary electrical connector.

In an exemplary embodiment, the drive interface of the rotatableassembly is a first drive interface configured to be operatively engagedwith a first drive system of the manipulation base, and the medicaldevice comprises at least one steering wire. In such an embodiment, therotatable assembly further comprises a control member disposed with thehousing and rigidly coupled with a steering wire of the medical device.The control member is configured for translational movement relative tothe longitudinal axis of the housing. The rotatable assembly furthercomprises a second drive interface coupled with the control member andconfigured to be operatively engaged with a second drive system of themanipulation base to impart translational movement onto the controlmember. In an exemplary embodiment, the housing of rotatable assemblyhas an axially extending slot therein, and the control member includes apin extending therefrom in a radial direction relative to thelongitudinal axis of the housing. The pin is disposed and configured fortravel within the slot in an axial direction relative to thelongitudinal axis, and the second drive interface is coupled with thepin.

In an exemplary embodiment, the control member is a first control memberand the steering wire coupled thereto is a first steering wire. In suchan embodiment. The rotatable assembly further comprises a second controlmember disposed with the housing and rigidly coupled to a secondsteering wire of the medical device. The second control member isconfigured for translational movement relative to the longitudinal axisof the housing. The rotatable assembly may further comprise a thirddrive interface coupled with the second control member and configured tobe operatively engaged with a third drive system of the manipulationbase to impart translation movement onto the second control member. Insuch an embodiment, the housing may further include an axially extendingslot therein, and the second control member may include a pin extendingtherefrom in a radial direction relative to the longitudinal axis. Thepin is disposed and configured for travel within the slot in an axialdirection relative to the longitudinal axis, and the third driveinterface is coupled with the pin.

The foregoing and other aspects, features, details, utilities, andadvantages of the present disclosure will be apparent from reading thefollowing description and claims, and from reviewing the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric diagrammatic view of a robotic control andguidance system, and a robotically controlled medical device guidancesystem, in particular, illustrating an exemplary layout of varioussystem components.

FIG. 2 is an isometric view of an exemplary drive assembly for use in arobotic control and guidance system such as that illustrated in FIG. 1.

FIG. 3 is an isometric view of an exemplary medical device cartridge ofthe drive assembly illustrated in FIG. 2.

FIG. 4 is an isometric view of the cartridge illustrated in FIG. 3 witha portion of the outer housing thereof to show the exemplary cartridgein greater detail.

FIG. 5 is an isometric view of an exemplary rotatable medical deviceassembly of the cartridge illustrated in FIGS. 3 and 4, wherein aportion of the housing thereof has been removed to show the exemplaryrotatable assembly in greater detail.

FIG. 6 is an enlarged isometric side view of a portion of the rotatableassembly illustrated in FIG. 5 showing, with particularity, a sliderblock of the rotatable assembly.

FIG. 7 is an isometric view of an exemplary manipulation base of thedrive assembly illustrated in FIG. 2.

FIG. 8 is an isometric view of the exemplary manipulation baseillustrated in FIG. 7, wherein a portion of the housing thereof, and thehousing of a commutator mounted thereon, have been removed to show theexemplary manipulation base in greater detail.

FIG. 9 is an isometric view of the exemplary manipulation baseillustrated in FIG. 8 showing the underside or bottom of themanipulation base.

FIG. 10 is an isometric view of the exemplary manipulation baseillustrated in FIGS. 7 and 8, wherein the mounting plate and supportframe thereof have been removed to show the manipulation base in greaterdetail.

FIG. 11 is an isometric view of the exemplary drive assembly illustratedin FIG. 2, wherein portions of the housings of the cartridge andmanipulation base thereof have been removed to show the exemplary driveassembly in greater detail.

FIG. 12 is an enlarged isometric view of a portion of the exemplarydrive assembly illustrated in FIG. 11 showing the operative engagementbetween a driven member of the manipulation base of the drive assembly,and a drive interface of the cartridge of the drive assembly in greaterdetail.

FIG. 13 is a diagrammatic and schematic view of electrical connectionsbetween components of the drive assembly illustrated in FIG. 2 and othercomponents of the robotic control and guidance system of which the driveassembly is a part.

DETAILED DESCRIPTION OF THE INVENTION

Before proceeding to a detailed description of a drive assembly for usein a robotically controlled guidance system (RCGS), a brief overview(for context) of an exemplary RCGS for manipulating one or more medicaldevices will first be provided. The description of the RCGS will, ingeneral terms, detail the various components of an exemplary RCGS.Following that description, the present specification will describe thedrive assembly for use in an RCGS.

Exemplary RCGS System Description.

Referring now to the drawings wherein like reference numerals are usedto identify identical components in the various views, FIG. 1illustrates one exemplary embodiment of a robotic control and guidancesystem 10 (RCGS 10) for manipulating one or more medical devices. TheRCGS 10 can be used, for example, to manipulate the location andorientation of catheters, such as, for example, mapping catheters, andsheaths in a heart chamber or in another body cavity or lumen. The RCGS10 thus provides the user with a similar type of control provided by aconventional manually-operated system, but allows for repeatable,precise, and dynamic movements. For example, a user such as anelectrophysiologist can identify locations (potentially forming a path)on a rendered computer model of the cardiac anatomy. The system can beconfigured to relate those digitally selected points to positions withina patient's actual/physical anatomy, and can thereafter command andcontrol the movement of the sheath and/or catheter to the definedpositions. Alternatively, a user can remotely control the movement ofthe sheath and/or catheter to a desired position within the patient'sanatomy. In any event, once at the specified target position, either theuser or the system can perform the desired diagnostic or therapeuticfunction. The RCGS 10 enables full robotic navigation/guidance andcontrol.

As shown in FIG. 1, the RCGS 10 can generally include one or moremonitors or displays 12, a visualization, mapping, and/or navigationsystem 14, a human input device and control system (referred to as“input control system”) 16, an electronic control system 18, amanipulator assembly (or head assembly) 20, and a manipulator assemblysupport structure 22 for positioning the manipulator assembly 20 inproximity to a patient or a patient's bed.

The displays 12 are configured to visually present to a user informationregarding patient anatomy, medical device location or the like,originating from a variety of different sources. The displays 12 caninclude, for example: a monitor 24 (coupled to system 14—described morefully below) for displaying cardiac chamber geometries or models,displaying maps and activation timing and voltage data to identifyarrhythmias, and for facilitating guidance of catheter movement; afluoroscopy monitor 26 for displaying a real-time x-ray image or forassisting a physician with catheter movement; an intra-cardiac echo(ICE) display 28 to provide further imaging; and an EP recording systemdisplay 30.

The visualization, navigation, and/or mapping system 14 is configured toprovide many advanced features, such as visualization, mapping,navigation support and positioning (i.e., determine a position andorientation (P&O) of a sensor-equipped medical device, for example, aP&O of a distal tip portion of a catheter). In an exemplary embodiment,the system 14 may comprise an impedance-based system, such as, forexample, the EnSite NavX™ system commercially available from St. JudeMedical, Inc., and as generally shown by reference to U.S. Pat. No.7,263,397 entitled “Method and Apparatus for Catheter Navigation andLocation and Mapping in the Heart,” the entire disclosure of which isincorporated herein by reference. In other exemplary embodiments,however, the system 14 may comprise other types of systems, such as, forexample and without limitation: a magnetic-field based system such asthe Carto™ System available from Biosense Webster, and as generallyshown with reference to one or more of U.S. Pat. No. 6,498,944 entitled“Intrabody Measurement,” U.S. Pat. No. 6,788,967 entitled “MedicalDiagnosis, Treatment and Imaging Systems,” and U.S. Pat. No. 6,690,963entitled “System and Method for Determining the Location and Orientationof an Invasive Medical Instrument,” the entire disclosures of which areincorporated herein by reference, or the gMPS system from MediGuideLtd., and as generally shown with reference to one or more of U.S. Pat.No. 6,233,476 entitled “Medical Positioning System,” U.S. Pat. No.7,197,354 entitled “System for Determining the Position and Orientationof a Catheter,” and U.S. Pat. No. 7,386,339 entitled “Medical Imagingand Navigation System,” the entire disclosures of which are incorporatedherein by reference; and a combination impedance-based and magneticfield-based system such as the Carto 3™ System also available fromBiosense Webster.

As briefly described above, in an exemplary embodiment, the system 14involves providing one or more positioning sensors for producing signalsindicative of medical device location (position and/or orientation)information. In an embodiment wherein the system 14 is animpedance-based system, the sensor(s) may comprise one or moreelectrodes. Alternatively, in an embodiment wherein the system 14 is amagnetic field-based system, the sensor(s) may comprise one or moremagnetic sensors (e.g., coils) configured to detect one or morecharacteristics of a low-strength magnetic field.

The input control system 16 is configured to allow a user, such as anelectrophysiologist, to interact with the RCGS 10, in order to controlthe movement and advancement/withdrawal of one or more medical devices,such as, for example, a catheter and/or a sheath (see, e.g., U.S. PatentPublication No. 2010/0256558 entitled “Robotic Catheter System,” andPCT/US2009/038597 entitled “Robotic Catheter System with DynamicResponse,” published as WO 2009/120982, the entire disclosures of whichare incorporated herein by reference). Generally, several types of inputdevices and related controls can be employed, including, withoutlimitation, instrumented traditional catheter/sheath handle controls,oversized catheter/sheath models, instrumented user-wearable gloves,touch screen display monitors, 2-D input devices, 3-D input devices,spatially detected styluses, and traditional joysticks. For a furtherdescription of exemplary input apparatus and related controls, see, forexample, U.S. Patent Publication Nos. 2011/0015569 entitled “RoboticSystem Input Device” and 2009/0248042 entitled “Model Catheter InputDevice,” the entire disclosures of which are incorporated herein byreference. The input devices can be configured to directly control themovement of the catheter and sheath, or can be configured, for example,to manipulate a target or cursor on an associated display.

The electronic control system 18 is configured to translate (i.e.,interpret) inputs (e.g., motions) of the user at an input device of theinput control system 16 (or from another source) into a resultingmovement of one or more medical devices (e.g., a catheter and/or asheath). In this regard, the system 18 includes a programmed electroniccontrol unit (ECU) in communication with a memory or other computerreadable media (memory) suitable for information storage. Relevant tothe present disclosure, the electronic control system 18 is configured,among other things, to issue commands (i.e., actuation control signals)to the manipulator assembly 20, and as will be described in greaterdetail below, to the drive assemblies thereof, in particular, to move orbend the medical device(s) associated therewith to prescribed positionsand/or in prescribed ways, all in accordance with the received userinput and/or a predetermined operating strategy programmed into thesystem 18. In addition to the instant description, further details of aprogrammed electronic control system can be found in U.S. PatentPublication No. 2010/0256558, the entire disclosure of which wasincorporated herein by reference above. It should be understood thatalthough the visualization, navigation, and/or mapping system 14 and theelectronic control system 18 are shown separately in FIG. 1, integrationof one or more computing functions can result in a system including anECU on which can be run both (i) various control and diagnostic logicpertaining to the RCGS 10 and (ii) the visualization, navigation, and/ormapping functionality of system 14.

Generally speaking, the manipulator assembly 20, in response to commandsissued by the electronic control system 18, is configured to maneuverthe medical device(s) associated therewith (e.g., translation movement,such as advancement and withdrawal of the medical device(s)), as well asto effectuate distal end (tip) deflection and/or rotation. Moreparticularly, in an embodiment, the manipulator assembly 20 can includea translation assembly 32 and one or more drive assemblies 34 mounted tosaid translation assembly 32. Each drive assembly 34 corresponds to arespective medical device that is to be controlled by the RCGS 10, andis configured to manipulate or maneuver the medical device in responseto commands issued by the electronic control system 18. Morespecifically, in the exemplary embodiment illustrated in FIG. 1, themanipulator assembly 20 may include a pair of drive head assemblies34—one configured to manipulate or maneuver a sheath associatedtherewith, and the other configured to manipulate or maneuver a catheterassociated therewith. In such an embodiment, the drive head assemblies34, as well as the translation assembly 32, may operate together tomaneuver the respective medical devices.

As further illustrated in FIG. 1, and as briefly described above, theRCGS 10 may further include a support structure 22 for supporting thehead assembly 20. The structure 22 can generally include a support frameincluding an attachment assembly for attachment to an operating bed. Aplurality of support linkages can be provided for accurately positioningone or more manipulator assemblies, such as the manipulator assembly 20.In another exemplary embodiment, the support structure 22 may furtherinclude wheels to allow for the support structure 22, and if mountedthereon, the manipulator assembly 20, to be easily moved.

Drive Assembly.

With reference to FIG. 2, in an exemplary embodiment, the drive assembly34 comprises a medical device cartridge 36 for an elongate medicaldevice, such as, for example, a sheath or a catheter (e.g., a spiralmapping catheter), and a manipulation base 38. As will be described ingreater detail below, the cartridge 36 and the manipulation base 38 areeach configured to allow the cartridge 36 to be removably attached tothe manipulation base 38.

With reference to FIGS. 3 and 4, in an exemplary embodiment, thecartridge 36 comprises an outer housing 40 and a rotatable medicaldevice assembly 42 (or rotatable assembly 42) disposed within the outerhousing 40 and comprising, among other components, an elongate medicaldevice 44. In an exemplary embodiment, some or all of the components ofthe cartridge 36 are disposable.

As illustrated in FIG. 3, the outer housing 40 is configured to housethe rotatable assembly 42, and is further configured shield the medicaldevice 44 and other components disposed in a sterile field that isexternal to the outer housing 40 (e.g., the patient table, drapes, thepatient, etc.) from contaminants, and therefore, to help maintainsterility. In an exemplary embodiment, the outer housing 40 is comprisedof multiple pieces that can be coupled together. For example, in anexemplary embodiment, the housing 40 comprises a first, or top portion46, and a second, or bottom portion 48. The first and second portions46, 48 are configured to interface with each other to allow the firstportion 46 to be detachably coupled with the second portion 48. Thefirst and second portions 46, 48 may be detachably coupled using anynumber of techniques known in the art. For example, the first and secondportions 46, 48 may be coupled by an interference or press fit. Inanother exemplary embodiment, the portions 46, 48 may be coupled bycomplementary interlocking members disposed on each portion. In stillother exemplary embodiments, conventional fasteners or any othertechniques described elsewhere herein or known in the art, may be used.In an exemplary embodiment, the first and second portions 46, 48 areformed of plastic, although the present disclosure is not meant to be solimited.

With continued reference to FIG. 3, in an exemplary embodiment, thefirst portion 46 has a first end 50 having a first opening 52 disposedtherein, and a second end 54 having a second opening 56 disposedtherein. In an exemplary embodiment, the openings 52, 56 are flangedopenings. The openings 52, 56 are configured to receive and supportrespective portions of the rotatable assembly 42, and to allow therotatable assembly 42 to rotate therein. Further, and as will bedescribed in greater detail below, in an exemplary embodiment, thesecond portion 48 comprises a base plate configured, in part, to allowthe cartridge 36 to be removably attached to the manipulation base 38.

It will be appreciated that while only a two-piece outer housing isdescribed with particularity herein, in other exemplary embodiments thehousing 40 may comprise more or less than two pieces, and suchembodiments remain within the spirit and scope of the presentdisclosure.

FIGS. 4 and 5 depict an exemplary embodiment of the rotatable assembly42 of the cartridge 36. In addition to the medical device 44, in anexemplary embodiment, the rotatable assembly 42 further comprises ahousing 58 configured, in part, to retain a portion (proximal end) ofthe medical device 44, an anchor member 60 disposed within housing 58,and one or more slider blocks 61 also disposed with the housing 58. Inan exemplary embodiment, the rotatable assembly 42 may further compriseone or more mechanical drive interfaces 62 configured to be operativelyengaged with corresponding drive systems of the mounting base 38 toimpart rotational movement onto the rotatable assembly 42; and one ormore mechanical drive interfaces 64 configured to be operatively engagedwith corresponding drive systems of the mounting base 38 to imparttranslational movement onto the one or more slider blocks 61 of therotatable assembly 42. The rotatable assembly 42 may still furthercomprise an electrical port 66 disposed in the housing 58 thereof. Aswill be described below, in an exemplary embodiment, the rotatableassembly 42 is configured to be supported by, and to rotate within, theflanged openings 52, 56 of the housing 40.

As briefly described above, the rotatable assembly 42 comprises anelongate medical device 44. The medical device 44 may comprise either asheath or a catheter, and more specifically, a rotary or spiral medicaldevice, such as, for example, a spiral mapping catheter. In any event,the medical device 44 comprises a shaft 68 having a proximal end 70 anda distal end 72 (best shown in FIG. 2). As will be described below, theproximal end 70 is disposed and retained within the housing 58 of therotatable assembly 42. The medical device 44 may further comprise one ormore sensors 74 disposed at or near the distal end 72 that may be usedfor a variety of diagnostic and/or therapeutic purposes including, forexample, EP studies, mapping, catheter identification and location,pacing, ablation, and the like. Each sensor 74 includes at least onelead wire (not shown) electrically connected thereto and extendingtherefrom to the proximal end 70 of the shaft 68. In an exemplaryembodiment, the lead wire(s) for each sensor 74 are electricallyconnected to the electrical port 66, as will be described in greaterdetail below. Accordingly, in such an embodiment, the lead wire(s) arerouted through the housing 58 of the rotatable assembly 42 and terminateat the electrical port 66. As briefly described above, the medicaldevice 44 may comprise a device configured to perform a mapping function(e.g., a spiral mapping catheter), or may comprise any number of othermedical devices, such as, for example, intracardiac echocardiography(ICE) catheters, catheters for use in high-intensity focused ultrasound(HIFU) ablation systems, or any other medical devices used in diagnosticor therapy delivery systems (e.g., ablation systems, drug deliverysystems, etc.) that require the medical device, or components thereof,to be focused in a given direction.

As is well known in the art, the medical device 44 may further compriseone or more steering wires 76 disposed within the shaft 68 andconfigured to cause the shaft 68 to deflect. For purposes ofillustration, the description below will be limited to an embodimentwherein the medical device 44 comprises two steering wires 76 (steeringwires 76 ₁, 76 ₂). It will be appreciated, however, that the presentdisclosure is not meant to be limited to such an embodiment, but ratherembodiments wherein the medical device 44 comprises more or less thantwo steering wires remain within the spirit and scope of the presentdisclosure. Each steering wire 76 has a proximal end and a distal end.The distal end of the steering wire 76 is rigidly coupled to a mountingstructure disposed within the shaft 68 of the medical device 44, suchas, for example, a pull ring. The proximal end, as will be describedbelow, is rigidly coupled to a control member disposed within thehousing 58 of the rotatable assembly 42.

As illustrated in FIGS. 4 and 5, in order to avoid buckling of theproximal end of the shaft 68 as a result of forces applied theretoduring use, in an exemplary embodiment, the medical device 44 furthercomprises a stiffening tube or strain relief 78 affixed to or joinedwith the shaft 68 at or near the proximal end 70 thereof. In anexemplary embodiment, the stiffening tube 78, which may be formed ofplastic, is disposed at such a location on the shaft 68 that one portionof the tube 78 extends into the housing 58 of the rotatable assembly 42,while another portion extends external to the housing 58.

With continued reference to FIGS. 4 and 5, the housing 58 of therotatable assembly 42 has a first end 80, a second end 82, and a cavity84. The housing 58 further defines a longitudinal axis 86 extendingthrough both the first and second ends 80, 82 thereof. In an exemplaryembodiment, the housing 58 is configured such that when the cartridge 36is assembled, the first end 70 thereof is disposed within and supportedby the flanged opening 52 of the housing 40, and the second end 82thereof is disposed within and supported by the flanged opening 56 ofthe housing 40. For reasons that will be described in greater detailbelow, the housing 58 may further include a first opening 88 disposed inthe first end 80 thereof, and a second opening 90 disposed in the secondend 82 thereof. The housing 58 is configured to, among other things,shield the components disposed therein from contaminants so as to helpmaintain the sterility of, for example, the medical device 44.

As illustrated in FIG. 4, in an exemplary embodiment, the housing 58 hasa substantially tubular shape. In such an embodiment, the housing 58 mayhave a constant outer diameter from the first end 80 thereof to thesecond end 82, or different portions of the housing 58 may havedifferent outer diameters. For example, as illustrated in FIG. 5, acenter portion of the housing 58 may have a first outer diameter, whilea portion of the housing 58 at the first end 80 thereof may have asecond outer diameter that is less than the first outer diameter, and aportion of the housing 58 at the second end 82 thereof may have a thirdouter diameter that is larger than both the first and second outerdiameters. In an exemplary embodiment, such as that illustrated in FIG.5, a first portion of the housing 58 at the first end 80 thereof mayhave an outer diameter sized to allow the first end 80 of the housing 58to be disposed within the flanged opening 52 of the outer housing 40. Insuch an embodiment, an adjacent portion of the housing 58 may have alarger outer diameter so as to form a shoulder 92 where the housing 58transitions between the two portions having different diameters. Theshoulder 92 may serve a positioning or orienting function when, in anembodiment, the first end 80 of the housing 58 is inserted into and/ordisposed within the flanged opening 52 in the housing 40. Similarly, asecond portion of the housing 58 at the second end 82 thereof may havean outer diameter sized to allow the second end 82 to be disposed withinthe flanged opening 56 of the outer housing 40.

As with the outer diameter, the housing 58 may also have a constantinner diameter throughout its length, or different portions of thehousing 58 may have different inner diameters. For example, asillustrated in FIG. 5, a center portion of the housing 58 may have afirst inner diameter, while a portion of the housing 58 at the first end80 thereof may have a second inner diameter that is less than the firstinner diameter, and a portion of the housing 58 at the second end 82thereof may have a third inner diameter that is larger than both thefirst and second inner diameters.

While both the housing 58 and the cavity 84 thereof have thus far beendescribed and depicted as having a circular cross-section, it will beappreciated that in other embodiments one or both of the housing 58 andthe cavity 84 may have a cross-sectional shape other than circular, andsuch embodiments remain within the spirit and scope of the presentdisclosure.

As illustrated in FIGS. 4 and 5, in an exemplary embodiment, and forreasons that will be described in greater detail below, the housing 58further comprises one or more slots 94 therein extending along thelength of the housing 58 in an axial direction relative to thelongitudinal axis 86. In an exemplary embodiment, the housing 58 has aplurality of axially extending slots 94. For example, the housing 58 maycomprise a pair of slots 94. In such an embodiment, the slots 94 may belinearly aligned or co-linear with each other (as illustrated in FIG. 4,for example). In another exemplary embodiment, the slots 94 may bediametrically opposed (i.e., disposed in different sides or portions ofthe housing 58 but in vertical alignment). In still another exemplaryembodiment, the housing 58 may comprise four axially extending slots 94.In such an embodiment, two of the slots 94 may be linearly aligned witheach other, while the second pair of slots 94 may also be linearlyaligned with each other but diametrically opposed to the first pair ofslots 94. Accordingly, it will be appreciated that the housing 58 mayinclude any number of axially-extending slots 94, and therefore,embodiments of the housing 58 having more or less slots 94 thandescribed herein remain within the spirit and scope of the presentdisclosure.

The housing 58 may be of a unitary construction or, alternatively, maybe formed of multiple pieces that when coupled together form the housing58. For example, in an exemplary embodiment, the housing 58 is comprisedof two pieces that are configured to be detachably coupled together. Thetwo pieces may be detachably coupled using any number of techniques wellknown in the art, such as, for example, those described above withrespect to the coupling of the first and second portions 46, 48 of thehousing 40. In addition, or alternatively, the pieces forming thehousing 58 may be held together by other components of the rotatableassembly 42, such as, for example, the drive interfaces 62, 64 describedbelow and illustrated in FIG. 4. In an exemplary embodiment, each pieceforming the housing 58, and therefore, the housing 58 itself, is formedof plastic, although the present disclosure is not meant to be solimited.

With continued reference to FIG. 5, and as briefly described above, therotatable assembly 42 further comprises an anchor member 60. The anchormember 60 is configured to receive and retain the proximal end 70 of themedical device 44. The anchor member 60 is disposed within the cavity 84of the housing 58 at the first end 80 thereof. The anchor member 60 isfurther disposed proximate the first opening 88 in the first end 80 ofthe housing 58, which is sized and configured to allow the medicaldevice 44 to extend outwardly from the housing 58 in an axial directionrelative to the longitudinal axis 86. Accordingly, the medical device 44extends from the anchor member 60 and out through the opening 88 in thehousing 58. Therefore, and as illustrated in FIG. 2, when the first end80 of the rotatable assembly 42 is disposed within the flanged opening52 in the cartridge outer housing 40, the opening 52 allows the medicaldevice 44 to extend outwardly from the cartridge outer housing 40.

In an exemplary embodiment, the anchor member 60 includes a passageway(not shown) therein that permits components of the medical device 44,such as, for example, sensor lead wires and steering wires 76, to passtherethrough for purposes that will be described in greater detailbelow. The anchor member 60 may be arranged such that the passageway iscoaxial to the longitudinal axis 86 of the housing 58. The anchor member60 may be held or restrained in place in a number of ways. For example,in an exemplary embodiment, the anchor member 60 is sized such that whenthe rotatable assembly 42 is assembled, the outer surface of the anchormember 60 is in contact or near contact with the inner surface of thecavity 84, and therefore, the housing 58 of the rotatable assembly 42holds the anchor member 60 in place. In addition, or alternatively,conventional fasteners and/or adhesives may be used. In an exemplaryembodiment, the anchor member 60 is formed of plastic, however, thepresent disclosure is not meant to be so limited.

As briefly described above, the rotatable assembly 42 still furthercomprises at least one or more control members or slider blocks 61. Forpurposes of illustration and clarity, the description below will belimited to an embodiment wherein the rotatable assembly 42 comprises twoslider blocks 61 (slider blocks 61 ₁, 61 ₂). It will be appreciated,however, that depending on the particular medical device 44, therotatable assembly 42 may comprise one, more than two, or no sliderblocks 61. Therefore, embodiments wherein the rotatable assembly 42comprises more or less than two slider blocks 61 remain within thespirit and scope of the present disclosure.

As illustrated in FIG. 5, the slider blocks 61 are disposed within thecavity 84 of the housing 58. Each slider block 61 is configured to berigidly coupled with a respective steering wire 76 of the medical device44 and for translational movement within the cavity 84 relative to thelongitudinal axis 86 of the housing 58. Accordingly, the slider block 61₁ is configured to be coupled with a first steering wire 76 ₁, and theslider block 61 ₂ is configured to be coupled to a second steering wire76 ₂. In an exemplary embodiment, each slider block 61 has a passagewayor channel 96 disposed therein. As with the anchor member 60 describedabove, the passageway 96 permits components of the medical device 44,such as, for example, sensor lead wires and the steering wires 76, topass therethrough. In an exemplary embodiment, the slider blocks 61 arearranged such that each passageway 96 is coaxial with the longitudinalaxis 86.

The steering wires 76 may be coupled with respective slider blocks 61 ina number of ways. For example, and with reference to FIG. 6, in oneembodiment, a slider block 61 includes a locking screw 98 disposedtherein. In such an embodiment, the steering wire 76 extends into thepassageway 96 of the slider block 61 and is interested into, forexample, a hole or slot in the locking screw 98, and is then wrappedaround a portion of the screw 98. The steering wire 76 may be wrappedaround the screw by rotating the exposed head of the screw 98, as isillustrated in FIG. 6. In such an embodiment, the slider block 61 mayfurther include a pin 100 that extends through a portion of the body ofthe slider block 61 and into a groove in the head of the screw 98. Thepin 100 prevents the screw 98 from rotating, and therefore, prevents thesteering wire 76 from unraveling.

As illustrated in FIG. 5, in an exemplary embodiment, each slider block61 further includes one or more dowel pins 102 outwardly extendingtherefrom in a radial direction relative to the longitudinal axis 86. Inan exemplary embodiment, the slider block 61 has a bore 104 therein thatis configured to receive the dowel pin 102. In an exemplary embodiment,the bore 104 is a closed bore such that the dowel pin 102 only extendsfrom only one side of the slider block 61. In an another exemplaryembodiment, such as that illustrated in FIG. 5, the bore 104 is athrough-bore such that the dowel pin 102 extends all the way through theslider block 61 and protrudes radially outwardly therefrom ondiametrically opposite sides of the slider block 61. While thedescription above has been with respect to a single dowel pin 102 and asingle bore 104, in other exemplary embodiment, the slider block 61 mayhave multiple dowel pins 102 disposed in one or more bores 104 therein,and such embodiments remain within the spirit and scope of the presentdisclosure.

In any event, when the rotatable assembly 42 is assembled, each dowelpin 102 extends through, and is configured to travel within, one or morerespective elongated slots 94 in the housing 58. The dowel pins 102 ofeach slider block 61 are configured to engage and be coupled with arespective drive interface 64 of the cartridge 36 to effect the movementof the slider blocks 61.

As will be described in further detail below, the distal portion of themedical device 44 can be deflected by selective tensioning of thesteering wire(s) 76 thereof. To that end, each slider block 61 isconfigured to translate within the cavity 84 to cause a tension responsein the steering wire 76 associated therewith. More particularly, and asmore fully described in PCT/US2011/030764 entitled “Intuitive UserInterface Control for Remote Catheter Navigation and 3D Mapping andVisualization Systems,” published as WO/2011/123669, the entiredisclosure of which is incorporated herein by reference, each sliderblock 61 can be translated in a proximal direction (i.e., away from theanchor member 60) to apply tension to the corresponding steering wire76, thereby causing a corresponding deflection in a direction toward thesteering wire 76. In an embodiment such as that described herein wherethere are two steering wires 76, and therefore, two slider blocks 61, asthe slider block 61 associated with a first steering wire 76 translatesin a first, proximal direction, the other slider block 61 reactivelymoves or retracts in a second, substantially opposing distal direction(i.e., toward the anchor member 60) to account for the tensioning of thefirst steering wire 76. By translating the slider blocks 61 along thelongitudinal axis 86, the medical device 44 can be deflected orstraightened as desired.

As briefly described above, in an exemplary embodiment, the rotatableassembly 42 further comprises an electrical port 66. As illustrated inFIGS. 4 and 5, the port 66 is disposed within the second end 82 of thehousing 58, and within the opening 90 thereof, in particular.Accordingly, in such an embodiment, the opening 90 is sized andconfigured to receive and retain the electrical port 66. The electricalport 66 has a first end 106 and a second end 108. The first end 106 isdisposed within the cavity 84 of the housing 58 and is configured to beelectrically coupled to, for example, one or more lead wires of one ormore sensors 74 of the medical device 44 that extend through the cavity84. The second end 108 is disposed external to the housing 58 andcomprises an electrical connector configured to be electrically coupledwith a complementary electrical connector.

For example, the second end 108 of the port 66 may comprise a male plugconnector having a plurality of pin contacts that is configured to bemated with a female receptacle connector having a plurality of socketcontacts, or vice versa. As will be described below, in an exemplaryembodiment, the electrical port 66, and the second end 108 thereof, inparticular, is configured to be electrically coupled with an electricalconnector of a commutator. Alternatively, the electrical port 66 may beelectrically coupled with an electrical connector of a cable or bus thatis, in turn, electrically connected to one or more other components ofthe RCGS 10. As illustrated in FIG. 2, for example, in an exemplaryembodiment, the second end 82 of the rotatable assembly 42 is sized andshaped to be disposed within the flanged opening 56 of the outer housing40. Accordingly, in such an embodiment, the electrical port 66 isdisposed within and is accessible through the opening 56 in the housing40.

As was briefly described above, in the embodiment illustrated in FIG. 4,the rotatable assembly 42 further comprises one or more drive interfaces62. Each drive interface 62 is fixedly coupled with the housing 58 ofthe rotatable assembly 42 and is configured to be engaged with a drivesystem of the manipulation base 38 to impart rotational movement ontothe rotatable assembly 42. In an embodiment wherein there are multipledrive interfaces 62, each drive interface 62 may be engaged with arespective drive system, or all of the drive interfaces 62 may beengaged with a common drive system. While the rotatable assembly 42 maycomprise any number of drive interfaces 62, for purposes ofillustration, the description below will be limited to an embodimentwherein the rotatable assembly 42 includes a single drive interface 62.

As illustrated in FIG. 4, in an exemplary embodiment, the driveinterface 62 comprises a collar that is fixedly mounted on and surroundsor circumscribes the housing 58 of the rotatable assembly 42. In anexemplary embodiment, the drive interface 62 is mounted on the housing58 at the first end 80 thereof, though the present disclosure is notmeant to be so limited. As illustrated in FIG. 4, in an exemplaryembodiment the drive interface 62 comprises a body 110 having athrough-bore 112 disposed therein that has a diameter slightly largerthan the outer diameter of at least a portion of the housing 58 to allowthe drive interface 62 to be placed over and onto the housing 58. Whilethe bore 112 is described and depicted herein as having a circularcross-section, it will be appreciated that the cross-sectional shapewill depend on the cross-sectional shape of the housing 58. Accordingly,embodiments wherein the bore 112 has a cross-sectional shape other thancircular remain within the spirit and scope of the present disclosure.

As will be described in greater detail below, in an exemplaryembodiment, at least a portion of the body 110 has a circularcross-section thereby defining an annular surface 114. The annularsurface 114 is configured to operatively engage a drive system of themanipulation base 38, which is configured to impart rotational movementonto the drive interface 62, and thus, the rotatable assembly 42, aboutthe longitudinal axis 86. In an exemplary embodiment, the driveinterface 62 comprises a gear, and therefore, the annular surface 114has a plurality of teeth extending outwardly therefrom. In anotherexemplary embodiment, however, the annular surface 114 is smooth.

In an embodiment wherein the medical device 44 comprises one or moresteering wires 76, and the rotatable assembly 42, therefore, comprisesone or more slider blocks 61, the rotatable assembly 42 furthercomprises a respective drive interface 64 for each slider block 61.Accordingly, with continued reference to FIG. 4, in an exemplaryembodiment wherein the rotatable assembly 42 comprises two slider blocks61, the rotatable assembly 42 also comprises two drive interfaces 64(drive interfaces 64 ₁, 64 ₂). Each drive interface 64 is coupled with arespective slider block 61 and is configured to be engaged with acorresponding drive system of the manipulation base 38 to imparttranslational movement onto the respective slider block 61.

As illustrated in FIG. 4, in an exemplary embodiment, each driveinterface 64 comprises a collar that surrounds or circumscribes thehousing 58 of the rotatable assembly 42. In such an embodiment, eachdrive interface 64 comprises a body 116 defining a longitudinal axis118, and has an axially-extending through-bore 120 disposed therein. Asillustrated in FIG. 4, the axis 118 is coaxial with the axis 86 of thehousing 58. The bore 120 has a diameter that is slightly larger than theouter diameter of at least a portion of the housing 58 to allow thedrive interface 64 to be placed over and onto the housing 58. While thebore 120 is described and depicted herein as having a circularcross-section, it will be appreciated that the cross-sectional shapewill depend on the cross-sectional shape of the housing 58. Accordingly,embodiments wherein the bore 120 has a cross-sectional shape other thancircular remain within the spirit and scope of the present disclosure.

As illustrated in FIG. 4, the body 116 of each drive interface 64further comprises one or more channels 122 therein, each configured toreceive one or more dowel pins 102 of the corresponding slider block 61.More particularly, each channel 122 extends within or through the body116 in a radial direction relative to the longitudinal axis 118 thereof.In an exemplary embodiment, the channels 122 extend through the body 116(i.e., extend from the surface of the bore 120 through the outer surfaceof the body 116) and when the drive interface 64 is mounted on thehousing 58 and is properly aligned with the slider block 61, isconfigured to allow for the dowel pin 102 to be inserted through thechannel 122, through the slot 94 in the housing 58, and into the bore104 in the slider block 61. In such an embodiment, the dowel pin 102 maybe further inserted into a second channel 122 diametrically opposing thefirst channel 122 such that the dowel pin 102 would extend through afirst channel 122, a first slot 94 in the housing 58, the port 104 inthe slider block 61, a second slot 94 in the housing 58, and a secondchannel 122.

While the description above is primarily with respect to the channels122 extending from the surface of the bore 120 through the outer surfaceof the body 116, in other embodiments, some or all of the channels 122may not extend all the way through the body 116, but rather may extendfrom the surface of the bore 120 to a point in the body 116 short of theouter surface thereof. For instance, in an exemplary embodiment, thebody 116 has a first channel 122 that extends from the surface of thebore 120 through the outer surface of the body 116, and a second channel122 that is disposed directly across the bore 120 from the first channel122 (i.e., diametrically opposed) and that extends from the surface ofthe bore 120 to a point short of the outer surface of the body 116. Insuch an embodiment, a dowel pin 102 may be inserted through the firstchannel 122, through a slot 94 in the housing 58, through the bore 104in the slider block 161, and then into the second channel 122 such thatthe pin 102 extends within, but not through, the body 116 relative tothe second channel 122.

As illustrated in FIG. 4, in an exemplary embodiment, the body 116further comprises a flange 124 at one axial end thereof extendingoutwardly therefrom in a radial direction relative to the longitudinalaxis 118. In such an embodiment, the channels 122 may be disposed withinthe flange 124. As will be described in greater detail below, in anexemplary embodiment, the flange 124 is configured to operatively engagea drive system of the manipulation base 38, which, as was brieflydescribed above, is configured to impart translational movement onto thedrive interface 64, thereby causing translational movement of thecorresponding slider block 61. The body 116 of the drive interface 64may be of a unitary construction, or alternatively, may be formed of aplurality of pieces that may be detachably joined together. In eitherinstance, the body 116 may be formed of plastic, though the presentdisclosure is not meant to be so limited.

As briefly described above, at least a portion of the cartridge housing40 comprises a base plate (base plate 48). In an exemplary embodimentsuch as that illustrated in FIG. 4, the base plate 48 includes one ormore recesses or indented portions 126. These recesses 126 are locatedsuch that when the rotatable assembly 42 is disposed within the housing40, the recesses 126 are proximate the drive interfaces 64. The recesses126 are sized and shaped to allow the drive interfaces 64 to freelyrotate as the rotatable assembly 42 rotates, and to move axially as thepin 102 corresponding thereto travels within the slot 94 in the housing58, without contacting the base plate 48. As also illustrated in FIG. 4,the base plate 48 may also include a plurality of apertures 128 (e.g.,128 ₁-128 ₅) therein that, as will be described more fully below, areconfigured to permit the operative engagement of the drive interfaces62, 64 with the respective drive systems of the manipulation base 38. Inan exemplary embodiment, each of the apertures 128 comprises anelongated slot (slot 128) that either extends axially or radiallyrelative to the longitudinal axis 86 of the housing 58 of the rotatableassembly 42. For example, in the particular embodiment described indetail herein, the base plate 48 comprises four axially extending slots128 (slots 128 ₁-128 ₄), and one radially extending slot 128 (slot 128₅).

In an exemplary embodiment, the base plate 48 further comprises one ormore sockets or recesses 130 configured to allow the cartridge 36 to beremovably attached to the manipulation base 38. More particularly, in anexemplary embodiment, one or more recesses or sockets 130 are configuredto receive and retain complementary locking pins or latch mechanisms,for example, of a mounting plate of the manipulation base 38. Therecesses or sockets 130 may include an interference lock such as aspring detect or other locking means. Alternatively, in anotherexemplary embodiment, the base plate 48 comprises one or more lockingpins or latch mechanisms that are configured to be mated with sockets orrecesses disposed in the mounting plate of the manipulation base 38.

As illustrated in FIG. 4, in an exemplary embodiment, the base plate 48may further include a memory or storage device 131, such as, for exampleand without limitation, an electrically erasable programmable read-onlymemory (EEPROM) or an radio-frequency identification (RFID) chip. Thememory 131 may contain, for example, identifying information relating tothe cartridge 36 and/or the various components thereof. The informationmay comprise for example, the make, model, serial number, physicaldimensions, special features, and/or calibration data related to themedical device 44 or the rotatable assembly 42. One exemplary purpose ofproviding this information relates to the instance wherein the use of acartridge 36 and associated rotatable assembly 42 or medical device 44thereof is restricted to a single use. Accordingly, the informationcontained in the memory 131 may be provided to allow the RCGS 10 todetermine, for example, whether a particular device associated with thememory 131 has been previously used, and if so, to provide an indicationto the user to remove that particular device or cartridge 36 from themanipulation base 38.

With reference to FIGS. 7-13, the manipulation base 38 will now bedescribed. In an exemplary embodiment and in general terms, themanipulation base 38 comprises a mounting plate 132, a support frame 134(best shown in FIG. 9) mounted onto the mounting plate 132, and ahigh-precision drive system 136 (best shown in FIGS. 9 and 10) that issupported by the support frame 134 and configured to operatively engageand impart rotational movement onto the drive interface 62 of thecartridge 36. In an exemplary embodiment, the manipulation base 38further comprises one or more high-precision drive systems 138 (bestshown in FIGS. 9 and 10) also supported by the support frame 134 andconfigured to operatively engage and impart translational movement ontorespective drive interfaces 64 of the cartridge 36. As described above,in an exemplary embodiment the cartridge 36, and the rotatable assembly42 thereof, in particular, comprises two drive interfaces 64, andtherefore, in such an embodiment the manipulation base 38 includes twodrive systems 138 (drive systems 138 ₁, 138 ₂), one for each driveinterface 64. As illustrated in FIGS. 7 and 8 and as will be describedin greater detail below, in an exemplary embodiment, the manipulationbase 38 may also still further comprise a commutator 140.

With particular reference to FIGS. 7 and 8, the mounting plate 132 has afirst end 142, a second end 144, and a longitudinal axis 146 extendingtherebetween. The mounting plate 132 further comprises a first side 148and a second side 150. The first side 148 is configured to have thecartridge 36 removably attached thereto. Accordingly, when the cartridge36 is attached to the manipulation base 38, the first side 148 of themounting plate 132 faces the cartridge base plate 48, while the secondside 150 faces away from the cartridge 36. In an exemplary embodiment,the first side 148 comprises one or more locking pins or latchingmechanisms 151 extending radially outwardly therefrom relative to thelongitudinal axis 146 that are configured to be mated with complementaryrecess or sockets 130 of the cartridge base plate 48. Alternatively, inan other exemplary embodiment, the first side 148 of the mounting plate132 may having one or more recesses or sockets (not shown) disposedtherein that are configured to receive and retain one or morecomplementary locking pins or latch mechanisms of the cartridge baseplate 48. In such an embodiment, the recesses or sockets may include aninterference lock such as a spring detect or other locking means.

With continued reference to FIGS. 7 and 8, the mounting plate 132further comprises a plurality of apertures 152 therein (e.g., 152 ₁-152₅). In an exemplary embodiment, each of the apertures 152 comprises anelongated slot (slot 152) that either extends axially or radiallyrelative to the axis 146 of the mounting plate 132. For example, in theparticular embodiment described in detail herein, the mounting plate 132comprises four axially extending slots 152 (slots 152 ₁-152 ₄), and oneradially extending slot 152 (slot 152 ₅). For reasons that will beapparent below, the arrangement of the slots 152 in the mounting plate132 may mirror that of the slots 128 in the cartridge base plate 48(i.e., the slots 152 of the mounting plate 132 will be aligned withcorresponding slots 128 of the base plate 48 when the base plate 48 andmounting plate 58 are arranged together). In an exemplary embodiment,the mounting plate 132 is formed of plastic, though the presentdisclosure is not meant to be so limited.

As illustrated in FIGS. 8 and 9, the second side 150 of the mountingplate 132 is configured to have the support frame 134 mounted thereto.The support frame 134 comprises a horizontal portion 154 (i.e.,extending axially relative to the axis 146) and one or more verticalportions 156 (i.e., extending radially relative to the axis 146). In theembodiment being described in detail herein, the support frame 134comprises two vertical portions 156 (vertical portions 156 ₁, 156 ₂). Asillustrated in FIG. 9, one side of the horizontal portion 154 is planar,and the other has the vertical portions 156 extending outwardlytherefrom. The planar side of the horizontal portion 154 is configuredto be affixed or mounted to the second side 150 of the mounting plate132, while each of the vertical portions 156 are configured to supportone or more of the drive systems 136, 138 of the manipulation base 38,and the output shafts of the motors thereof, in particular.

The support frame 134 may be mounted to the mounting plate 132 in anumber of ways. For example, conventional fasteners may be used to affixthe support frame 134 to the mounting plate 132. Alternatively, anadhesive may be used, or the frame 134 may be removably or detachablycoupled to the mounting plate using any number of techniques known inthe art, including, for example and without limitation, those describedelsewhere herein. Further, the support frame 134 may be formed ofplastic, though the present disclosure is not meant to be so limited.

As briefly described above and with reference to FIGS. 9 and 10, themanipulation base 38 comprises at least one drive system 136. In anexemplary embodiment, the drive system 136 comprises a rotary actuatorconfigured to operatively engage and impart rotational movement onto thedrive interface 62 of the cartridge 36. In such an embodiment, therotary actuator may comprise an electric rotary motor 158 having anoutput shaft 160. In an embodiment, the axis of rotation of the outputshaft 160 is parallel to, and, in an exemplary embodiment, verticallyaligned with, the longitudinal axis 146 of the mounting plate 132. In anexemplary embodiment, the drive system 136 is mounted to the second side150 of the mounting plate 132 by the support frame 134. Moreparticularly, the vertical portion 156 ₁ of the support frame 134comprises an aperture therein that is configured to receive the outputshaft 160 of the motor 158. The support frame 134 is configured tosupport the motor 158 and to ensure that it is properly oriented withrespect to other components of the drive system 136.

As best shown in FIG. 10, the drive system 136 further comprises arotatable member 162 coaxially arranged with, and mounted on, the outputshaft 160. In an exemplary embodiment, the rotatable member 162comprises an external gear. In another exemplary embodiment, therotatable member 162 comprises a wheel having a smooth annular surface(i.e., no teeth). The particular configuration of the rotatable member162 will depend, at least in part, on the configuration of the driveinterface 62 of the cartridge 36 (e.g., whether the drive interface 62comprises a gear or has a smooth annular surface 114). In any event, inan exemplary embodiment, the rotatable member 162 is configured tooperatively engage the drive interface 62 and to impart the rotationalmotion generated by the motor 158 onto the drive interface 62, andtherefore, the rotatable assembly 42 of the cartridge 36. Moreparticularly, in an exemplary embodiment, the rotatable member 162 isaligned with and partially extends through, the slot 152 ₅ in themounting plate 132. The rotatable member 162 extends far enough throughthe slot 152 ₅ that when the cartridge 36 is attached to the mountingplate 132, a portion of the rotatable member 156 also extends throughthe slot 128 ₅ in the cartridge base plate 48. The rotatable member 162extends far enough through the slot 128 ₅ that it operatively engagesthe annular surface 114 of the drive interface 62. Accordingly, in anembodiment wherein the annular surface 114 and the annular surface ofthe rotatable member 162 are each smooth, the operative engagementbetween the drive interface 62 and the rotatable member 162 comprises afriction interface, while in an embodiment wherein the drive interface62 and the rotatable member 162 each comprise gears, the operativeengagement comprises a gear arrangement.

In another exemplary embodiment, rather than the rotatable member 162directly engaging the drive interface 62, a second rotatable member 164is disposed between and operatively engages both the drive interface 62and the first rotatable member 162. Thus, in such an embodiment, thesecond rotatable member 164 is configured to impart the rotationalmotion generated by the motor 158 onto the drive interface 62, andtherefore, the rotatable assembly 42. As with the first rotatable member162, in an exemplary embodiment, the second rotatable member 164comprises an external gear. In another exemplary embodiment, the secondrotatable member 164 comprises a wheel having a smooth annular surface(i.e., no teeth). The particular configuration of the second rotatablemember 164 will depend, at least in part, on the configuration of boththe rotatable member 162 and the drive interface 62 of the cartridge 36(e.g., whether the rotatable member 162 and the drive interface 62comprise gears or have smooth annular surfaces).

In exemplary embodiment, the second rotatable member 164 is mounted tothe mounting plate 132 in such a manner that it is operatively engagedwith the first rotatable member 162, and its axis of rotation isparallel to and vertically aligned that of the output shaft 160. Moreparticularly, in an exemplary embodiment such as that illustrated inFIG. 9, the mounting plate 132 has a pair of axially spaced mountingtabs 166 that extend radially outwardly (e.g., downward) from the secondsurface 150 relative to the longitudinal axis 146 of the mounting plate132. In an exemplary embodiment, the tabs 166 are disposed ondiametrically opposite sides of the slot 152 ₅ such that when the secondrotating member 164 is mounted to the mounting tabs 166, at least aportion of the rotatable member 164 is disposed within, and extendsthrough, the slot 152 ₅. The second rotatable member 164 extends farenough through the slot 152 ₅ that when the cartridge 36 is attached tothe mounting plate 132, a portion of the second rotatable member 164also extends through the slot 128 ₅ in the cartridge base plate 48. Thesecond rotatable member 164 also extends far enough through the slot 128₅ that it operatively engages the annular surface 114 of the driveinterface 62. Accordingly, in an embodiment wherein the annular surface114 and the annular surfaces of the rotatable members 162, 164 are eachsmooth, the operative engagement therebetween comprises a frictioninterface, while in an embodiment wherein the drive interface 62 and therotatable members 162, 164 each comprise gears, the operative engagementcomprises a gear arrangement.

Whether the rotatable member 162 or the second rotatable member 164engages the drive interface 62, the drive system 136 is configured toimpart rotational movement onto the drive interface 62, and thus, therotatable assembly 42. Accordingly, if rotation in a first direction isdesired, the drive system 136 is configured to cause the motor 158 torotate the output shaft 160 thereof in the appropriate direction toachieve the desired rotation. As will be described in greater detailbelow, the drive system 136, and the motor 158 thereof in particular, iselectrically coupled to, and configured to be controlled by, one or moremotor controllers in the manner described below.

While the description above has been primarily with respect to anembodiment wherein the drive system 136 is disposed below or underneaththe drive interface 62 when the cartridge 36 and manipulation base 38are assembled together, the present invention is not meant to be solimited. For example, in another exemplary embodiment, the drive system136 may be axially arranged with the drive interface 62 with respect tothe longitudinal axis 86 of the rotatable medical device assemblyhousing 58 (i.e., the drive system 136 may be disposed in front of orbehind the rotatable medical device assembly 42). Accordingly, in suchan embodiment, the motor 158 of the rotary actuator of the drive system136 may mounted on the first side 148 of the mounting plate 132 and havea an output shaft 160 that is configured to operatively engage the driveinterface 62 and to impart rotational movement onto the rotatablemedical device assembly 42. For example, in an exemplary embodiment, theshaft (shaft 204, as will be described below) of the commutator 140 maybe operatively engaged with the drive interface 62 and be configured tobe driven by the motor 158 of the drive system 136 to impart rotationalmovement onto the drive interface 62, and therefore, the rotatablemedical device assembly 42. Alternatively, the drive interface 62 may beoperatively engaged with, and driven directly by, the output shaft 160of the motor 158.

As briefly described above, and with continued reference to FIGS. 9 and10, in an exemplary embodiment, the manipulation base 38 furthercomprises one or more drive systems 138 configured to imparttranslational movement onto respective drive interfaces 64 of thecartridge 36. As described above, in an exemplary embodiment, thecartridge 36, and the rotatable assembly 42 thereof, in particular,comprises two drive interfaces 64, and therefore, in such an embodimentthe manipulation base 38 includes two drive systems 138 (drive systems138 ₁, 138 ₂)—one for each drive interface 64.

With particular reference to FIG. 10, in an exemplary embodiment, eachof the drive systems 138 comprises an electromechanical device that isconfigured to operatively engage and impart translational movement ontoa respective drive interface 64. More specifically, the drive system maycomprise an electric motor 168 and a motor-driven ball screw. The ballscrew comprises a screw portion 170 coupled to the output shaft of themotor 168 by a coupler 172, and a ball nut 174 that is configured totravel along the screw 170 as it is rotated by the motor 168. In anexemplary embodiment, each of the ball nuts 174 are configured to travelin an axial direction relative to the longitudinal axis 146 of themounting plate 132. While the description below will be limited to anembodiment wherein the drive system 138 comprises a motor-driven ballscrew, it will be appreciated that the present disclosure is not meantto be so limited. Rather, in other exemplary embodiments, the drivesystem 138 may comprise devices or components other than a ball screw,such as, for example, a motor-driven lead screw, a linear motor, astepper motor drive configured to drive a belt, and other like devices,and such embodiments remain within the spirit and scope of the presentdisclosure.

As with the drive system 136 described above, in an exemplaryembodiment, each drive system 138 is mounted onto the second side 150 ofthe mounting plate 132 by the support frame 134. More particularly, andwith reference to FIG. 9, the vertical portion 156 ₂ of the supportframe 134 comprises a pair of apertures therein that are configured toreceive the output shafts of the motors 168 (or the coupler 172 thatcouples the output shaft to the screw 170). The support frame 134 isconfigured to support the motors 168 and to ensure that each one isproperly oriented or aligned with respect to the other components of therespective drive system 138.

Each of the drive systems 138 further comprises a driven member 176configured to be driven by the respective motor 168 and ball screwcombination. With reference to FIG. 10, in an exemplary embodiment, thedriven member 176 is integral with, or fixedly coupled to (e.g., usingconventional fasteners) a bearing block 178, which, in turn, is moveablycoupled to a corresponding bearing rail 180. In the illustratedembodiment, the bearing rail 180 is mounted on the second side 150 ofthe mounting plate 132. Accordingly, as the driven member 176 is drivenby the motor 168 and ball screw of the corresponding drive system 138,the driven member 176 and the bearing block 178 travel along the bearingrail 180.

In an exemplary embodiment, the bearing blocks 178 corresponding to therespective driven members 176 are coupled to the same bearing rail 180.In another exemplary embodiment, however, each bearing block 178 may becoupled to a respective bearing rail 180. In either instance, thebearing rail 180 may take the form of a track upon which a bearing block178 may be mounted and along which it may travel. In the embodimentdescribed in detail herein, each of the bearing blocks 178 are mountedon a common bearing rail 180, and the bearing rail 180 has alongitudinal axis that is parallel to the longitudinal axis 146 of themounting plate 132. Further, in an exemplary embodiment, each of thedriven members 176, the bearing blocks 178, and the bearing rail 180 areformed of plastic, though the present disclosure is not intended to beso limited.

As illustrated in FIGS. 7-10, in an exemplary embodiment, each of thedriven members 176 comprises a drive fork. While the description belowwill be primarily with respect to such an embodiment, it will beappreciated that the present disclosure is not meant to be limited tosuch an embodiment, but rather embodiments wherein the driven member 176is other than a drive fork remain within the spirit and scope of thepresent disclosure. Accordingly, as illustrated in FIG. 10, each of thedriven members 176 comprises a base 182 and a pair of prongs 184extending outwardly from the base 182. Each prong 184 defines arespective longitudinal axis 186 that is perpendicular to the axis 146of the mounting plate 132, and that is also disposed in a plane that isperpendicular to the plane in which the axis 146 is disposed.

In an exemplary embodiment, the base 182 is coupled to or integral withthe bearing block 178 described above. Further, each of the prongs 184extend axially relative to the longitudinal axis 186 thereof from thebase 182, and through a corresponding slot 152 in the mounting plate132. More particularly, the first prong 184 ₁ of the driven member 176corresponding to the drive system 138 ₁ extends through the slot 152 ₂and is configured to travel therein in an axial direction relative tothe axis 146 of the mounting plate 132. Similarly, the second prong 184₂ extends through the slot 152 ₄ that is next to the slot 152 ₂, and isconfigured to travel therein in an axial direction relative to the axis146. As illustrated in FIG. 11, each of the prongs 184 ₁, 184 ₂ of thedriven member 176 of the drive system 138 ₁ extend far enough throughthe slots 152 ₂, 152 ₄ that when the cartridge 36 is attached to themanipulation base 38, the prongs 184 ₁, 184 ₂ also extend through thecorresponding slots 128 in the cartridge base plate 48. The prongs 184₁, 184 ₂ extend far enough through the slots respective slots 128 in thebase plate 48 that they operatively engage the flange 124 of the driveinterface 64 ₁.

As with the driven member 176 of the drive system 138 ₁, the first prong184 ₁ of the driven member 176 corresponding to the drive system 138 ₂extends through the slot 152 ₁ and is configured to travel therein in anaxial direction relative to the axis 146 of the mounting plate 132.Similarly, the second prong 184 ₂ extends through the slot 152 ₃ that isnext to the slot 152 ₁, and is configured to travel therein in an axialdirection relative to the axis 146. As illustrated in FIG. 11, each ofthe prongs 184 ₁, 184 ₂ of the driven member 176 corresponding to thedrive system 138 ₂ extend far enough through the slots 152 ₁, 152 ₃ thatwhen the cartridge 36 is attached to the manipulation base 38, theprongs 184 ₁, 184 ₂ also extend through the corresponding slots 128 inthe cartridge base plate 48. The prongs 184 ₁, 184 ₂ extend far enoughthrough the respective slots 128 that they operatively engage the flange124 of the drive interface 64 ₂.

As illustrated in FIG. 10, each driven member 176 is coupled to arespective ball nut 174. In an exemplary embodiment, the driven member176 and the ball nut 174 may be directly coupled together. In anotherexemplary embodiment, such as that illustrated in FIG. 10, for example,the driven member 176 is indirectly coupled to the ball nut 174. Moreparticularly, the ball nut 174 may have a coupling 188 attached thereto.In an exemplary embodiment, the ball nut 174 is coupled with thecoupling 188 using conventional fasteners. The coupling 188, in turn,and for reasons that will be described below, may be attached to a forcesensor 190, such as, for example and without limitation, a strain gauge(strain gauge 190). The strain gauge 190 is then coupled with the drivenmember 176. In an exemplary embodiment, the strain gauge 190 is coupledwith both the driven member 176 and the coupling 188 using conventionalfasteners. Accordingly, as the ball nut 174 travels along the screw 170,the corresponding driven member 176 travels along the bearing rail 180in the same direction the ball nut 174 travels. Alternatively, inanother exemplary embodiment wherein the drive system 138 does notinclude a force sensor 190 such as that described above, the drivenmember 176 may be directly coupled to the coupling member 188.

With reference to FIG. 11, because the respective driven members 176 ofthe drive systems 138 ₁, 138 ₂ (and the prongs 184 thereof, inparticular) are operatively engaged with respective drive interfaces 64of the cartridge 36, translational movement may be imparted onto aparticular drive interface 64 by translating the driven member 176engaged with that drive interface 64. Thus, translating a driven member176 results in the translation of the corresponding drive interface 64,and therefore, the slider block 61 coupled thereto, thereby resulting inthe manipulation of the steering wire 76 associated with the sliderblock 61. Accordingly, if deflection of the medical device 44 in a givendirection is desired, the drive system 138 operatively engaged with thedrive interface 64 coupled to the slider block 61 corresponding to theappropriate steering wire 76 causes the driven member 176 thereof totranslate in the direction that will result in the tensioning of thesteering wire 76, thereby resulting in the deflection of the medicaldevice 44. On the other hand, if deflection of the medical device in adifferent direction from that associated with a given steering wire 76,the drive system 138 may be further configured to cause the drivenmember 176 corresponding to that steering wire 76 to translate in adirection that will reduce the tensioning of the steering wire 76 so asto not impede the deflection of the medical device.

For example, and with reference to FIG. 11, in the instance wherein thesteering wire 76 ₁ corresponding to the slider block 61 ₁ is to betensioned, the drive system 138 ₁ causes the ball nut 174 thereof totranslate in a proximal direction (i.e., away from the anchor member 60or distal end of the medical device 44). As a result, the driven member176 corresponding thereto translates in the proximal direction, therebyapplying a force onto the drive interface 64 ₁ (i.e., the flange 124thereof, or the surface of the interface 64 ₁ facing the driven member176) resulting in the translation of the slider block 61 ₁ in a distaldirection, and therefore, the tensioning of the steering wire 76 ₁. Toaccount for the tensioning of the steering wire 76 ₁, the drive system138 ₂ may cause the ball nut 174 thereof to translate in a distaldirection (i.e., toward the anchor member 60 or distal end of themedical device 44). As a result, the driven member 176 correspondingthereto translates in the distal direction, thereby allowing the sliderblock 61 ₂ to also translate in the distal direction so as to not impedethe tensioning of the steering wire 76 ₁. Accordingly, each of the drivesystems 138 is configured allow or to impart translational movement ontoa respective drive interface 64, and thus, the slider block 61 coupledthereto. As will be described in greater detail below, each drive system138, and the motors 168 thereof in particular, are electrically coupledto, and configured to be controlled by, one or more motor controllers inthe manner described below.

In addition to the above, in an exemplary embodiment such as thatdescribed herein, the driven members 176, and the prongs 184 thereof, inparticular, may each comprise one or more rollers 192 configured tofacilitate the rotation of the rotatable assembly 42 (i.e., to reducethe friction between the driven member 176 and the drive interface 64).More particularly, in an exemplary embodiment, each prong 184 of eachdriven member 176 comprises a roller 192. Accordingly, the body of eachprong 184 has a recess 194 therein within which a roller 192 is mounted.As illustrated in FIG. 12, for example, the roller 192 partiallyprotrudes from the recess 194 to such a degree that it contacts thesurface of the corresponding drive interface 64. As a result, the driveinterface 64 is allowed to roll along the roller 192 as the rotatableassembly 42 rotates. The rollers 192 may be formed of plastic or rubber,though the present disclosure is not intended to be so limited. While inthe embodiment described and depicted herein each prong 184 of eachdriven member 176 includes a single roller 192, it will be appreciatedthat in other exemplary embodiments, either none or less than all of theprongs 184 may have rollers 192, or one or more prongs 184 may have morethan one roller 192.

As briefly mentioned above, and as illustrated in FIG. 13, in anexemplary embodiment each of the drive systems 136, 138 are electricallycoupled to, and configured to be controlled by, one or more motorcontrollers 196. In an exemplary embodiment, the manipulation base 38includes a dedicated motor controller 196 for each drive system 136,138, or for groups of drive systems (e.g., one for the drive system 136and another for the drive systems 138). In another exemplary embodimentsuch as that described herein, the manipulation base 38 comprises asingle motor controller 196 configured to control all of the drivesystems 136,138 of the manipulation base 38. In an exemplary embodiment,the motor controller 196 includes a bus interface to facilitate exchangeof information between the drive systems 136, 138 and, for example, theelectronic control system 18 via a bus. In an embodiment, either thesame bus interface, or one or more additional bus interfaces associatedwith the manipulation base 38 or the individual drive systems 136, 138thereof, may be configured to provide operating power to the motors ofthe drive systems 136, 138. Alternatively, the manipulation base 38 mayhave a bus interface that is electrically coupled to the motorcontroller 196 and each of the drive systems 136, 138 to facilitate thecommunication and provision of power described herein.

In any event, the motor controller 196 communicates with the electroniccontrol system 18 (or another component of the RCGS) via the businterface and is configured to, among other things receive and executemotor control commands issued by the electronic control system 18 forcontrolling the movement of the respective motors 158, 168 of the drivesystems 136, 138. Thus, in an exemplary embodiment, a user may input acommand relating to a particular desired movement of the medical device44 (e.g., rotation or deflection in a certain direction) via the inputcontrol system 16. The electronic control system 18 may translate orinterpret the command, and then issue motor control commands to themotor controller 196, which then controls the appropriate motors 158,168 in the appropriate way to effectuate or carry out the desiredmovement of the medical device 44. In an exemplary embodiment, the motorcontroller 196 is mounted on the mounting plate 132 of the manipulationbase, though the present disclosure is not meant to be so limited.

As described above, in an exemplary embodiment the drive systems 138each comprise a force sensor 190, such as, for example a strain gauge,coupled to the driven member 176. The strain gauge 190 is configured tomeasure the actuation forces being applied by the drive system 138 tothe drive interface 64, and therefore, the tension of the steering wire76 corresponding thereto. The strain gauge 190 is electrically coupledto the motor controller 196, the electronic control system 18, or both,and is configured to communicate the measured force being applied to thedrive interface 64, and therefore, the corresponding steering wire 76.One purpose of employing a force sensor is to ensure that at least aminimum contact force between the driven member 176 and the driveinterface 64 is maintained. More particularly, in certain instances itmay be beneficial to maintain a minimum tension on all steering wires76, even when such a steering wire 76 (and the slider block 61corresponding thereto) is reactively translating in the distaldirection, as was described above. Such minimal tension can help ensurethat no undesirable measure of slack is created in any steering wire 76that could potentially cause an unresponsive state (even if onlymomentarily) during a transition from a motion in one direction tomotion in another direction. Accordingly, by incorporating the forcesensor 190 in the manner set forth herein, the slider blocks 61 can beallowed to freely retract yet avoid contact latencies.

Thus, through the motor controller 196, each driven member 176 can becontrollably positioned such that a minimal contact force between thedriven member 176 and the corresponding drive interface 64, andtherefore, the slider block 61, is always maintained. This ensures thatall passive steering wires 76 (i.e., those not being actively tensioned)are maintained in a “ready state” yet are not significantly impeded(i.e., the slider blocks 61 corresponding to the passive steering wires76 can still retract).

While the description above has been thus far with respect to the forcesensor 190 comprising a force sensor that is attached to the drivenmember 176, the present disclosure is not meant to be so limited.Rather, in other exemplary embodiments, the force sensor 190 may bedisposed within the shaft of the medical device 44 at or near the distalend thereof. In another exemplary embodiment, the force sensor 190 maycomprise a motor current sensor that is electrically connected to themotor 168 of the drive system 138. In such an embodiment, the motorcurrent sensor is configured to measure the current drawn by the motor168 to thereby measure the actuation forces being applied by the drivesystem 138 to the drive interface 64, and therefore, the tension of thesteering wire 76 corresponding thereto. In any event, and as withembodiment described above wherein the force sensor 190 comprises, forexample, a strain gauge, and for the same purposes, the force sensordisposed within the shaft of the medical device 44 or the motor currentsensor may be electrically coupled to the motor controller 196, theelectronic control system 18, or both, either directly or indirectly(e.g., through the commutator 140, in the instance where the forcesensor is disposed within the medical device 44, for example) and isconfigured to communicate the measured force being applied to thecorresponding steering wire 76. In at least certain instances, the forcesensor 190 provides a suitable way to perform mechanically isolatedforce sensing that minimizes external friction and forces, andtherefore, provides a precise and accurate measurement of the forcebeing applied to the corresponding steering wires 76.

As illustrated in FIG. 7, in an exemplary embodiment, the manipulationbase 38 further comprises a housing 198 within which the drive systems131, 138 and, in certain instances, other components of the manipulationbase 38 are housed. The purpose of the housing 198 is to shield themedical device 44 and other components disposed in a sterile field thatis external to the housing 198 (e.g., the patient table, drapes, thepatient, etc.) from contaminants, and therefore, the help maintainsterility. In the embodiment illustrated in FIG. 7, the housing includesa first portion comprised of the mounting plate 132, and a secondportion 200 that is detachably coupled with the mounting plate 132. Inexemplary embodiment, the second portion 200 is formed of plastic,though the present disclosure is not meant to be so limited. The firstand second portions of the housing 198 may be detachably coupledtogether using any number of techniques known in the art, including, butnot limited to, those described elsewhere herein.

As illustrated in FIGS. 7 and 8, and as briefly described above, in anexemplary embodiment, the manipulation base 38 may further comprise acommutator 140. The commutator 140 is mounted on the mounting plate 132on the same side that the cartridge 36 is attached to and has an housing202 (best shown in FIG. 7) and a rotatable shaft 204 protrudingtherefrom. The commutator 140 is positioned on the mounting plate 132 insuch a manner that when the cartridge 36 is attached to the mountingplate 132, the shaft 204 of the commutator 140 protrudes towards thecartridge 36 and is arranged coaxially with the opening 56 in thecartridge housing 40 and the port 66 of the rotatable assembly 42 toallow an electrical connector disposed at the distal end of the shaft204 to be coupled with the electrical connector of the port 66.Accordingly, the commutator 140 has an electrical connector disposed atthe end of the shaft 204 that is complementary to that of the port 66.As is known in the art, the input shaft 204 is configured to rotate suchthat as the rotatable assembly 42 of the cartridge 36 rotates, the shaft204 also rotates without impeding the rotation of the rotatable assembly42. Further, in an exemplary embodiment, the input shaft 204 isspring-loaded such that it can be pushed in towards the housing 202 toallow the cartridge 36 to be attached to the mounting plate 132, andthen released to cause the shaft 204 to extend and be coupled to theport 66.

As illustrated in FIG. 8, the commutator 204 further comprises anelectrical port 206. The electrical port 206 comprises an electricalconnector configured to be electrically coupled with a complementaryelectrical connector of an electrical cable. For example, the port 206may comprise a male plug connector having a plurality of pin contactsthat is configured to be mated with a female receptacle connector havinga plurality of socket contacts, or vice versa. The port 206 iselectrically connected to the electrical connector of the shaft 204, andprovides a means by which electrical signals acquired or generated bysensors 74 of the medical device 44 can be communicated to othercomponents of the RCGS 10. More particularly, because the lead wires ofsensors 74 are electrically coupled to the port 66, the port 66 iselectrically coupled to the electrical connector of the commutator shaft204, and the electrical connector of the commutator shaft 204 iselectrically connected to the port 206, the electrical signals from thesensors 74 may be communicated to other components of the RCGS 10through the commutator 140.

With reference to FIG. 2, in addition to the cartridge 36 and themanipulation base 38, in an exemplary embodiment, the drive headassembly 34 further comprises a sterility barrier 208 disposed betweenthe base plate 48 of the cartridge 36 and the mounting plate 132 of themanipulation base 38. The purpose of the sterility barrier 208 is toshield the components of the cartridge 36, and other components disposedin a sterile field that is external to the cartridge outer housing 40and the manipulation base housing 198, from contaminants, and therefore,help maintain the sterility of the medical device 44 and the sterilefield. In an exemplary embodiment, the sterility barrier 208 is formedof polyethylene. In another exemplary embodiment, the barrier 208 isformed of polycarbonate. It will be appreciated that while only thosematerials set forth above have been specifically identified, in otherexemplary embodiments the barrier 208 may be formed of materials orcombinations of materials in addition to or other than those identifiedherein, and such embodiments remain within the spirit and scope of thepresent disclosure.

In an exemplary embodiment, in order to permit the engagements betweenthe drive systems 136, 138 of the manipulation base 38 and the driveinterfaces 62, 64 of the cartridge 36 described above, the barrier 208has the same “layout” as that of the base plate 48 and mounting plate132. More particularly, in such an embodiment the barrier 208 has thesame number and arrangement of apertures or slots disposed therein asthe base plate 48 and mounting plate 132. Similarly, the barrier 208will further include the necessary apertures therein to allow for thecartridge 36 to be attached to the manipulation base 38. In an exemplaryembodiment, the barrier 208 may be part of a larger bag assembly thatmay encapsulate the entire drive assembly 34, or one or the other of thecartridge 36 and drive assembly 48.

Although only certain embodiments have been described above with acertain degree of particularity, those skilled in the art could makenumerous alterations to the disclosed embodiments without departing fromthe scope of this disclosure. Joinder references (e.g., attached,coupled, connected, and the like) are to be construed broadly and mayinclude intermediate members between a connection of elements andrelative movement between elements. As such, joinder references do notnecessarily infer that two elements are directly connected/coupled andin fixed relation to each other. Additionally, all directionalreferences (e.g., top and bottom) are only used for identificationpurposes to aid the reader's understanding of the present invention, anddo not create limitations, particularly as to the position, orientation,or use of the invention. Further, the terms electrically connected andin communication are meant to be construed broadly to encompass bothwired and wireless connections and communications. It is intended thatall matter contained in the above description or shown in theaccompanying drawings shall be interpreted as illustrative only and notlimiting. Changes in detail or structure may be made without departingfrom the invention as defined in the appended claims.

1-10. (canceled)
 11. A manipulation base for use with a medical devicecartridge in a robotically controlled medical device guidance system,comprising: a mounting plate configured to have a medical devicecartridge removably attached thereto and defining a longitudinal axis;and a drive system mounted to said mounting plate, wherein said drivesystem comprises a rotary actuator and is configured to operativelyengage a drive interface of said cartridge and to impart rotationalmovement onto said drive interface of said cartridge.
 12. Themanipulation base of claim 11, wherein said drive system is a firstdrive system and said drive interface of said cartridge is a first driveinterface, said manipulation base further including a second drivesystem mounted to said mounting plate, wherein said second drive systemcomprises an electromechanical device and is configured to operativelyengage a second drive interface of said cartridge and to imparttranslational movement onto said second drive interface.
 13. Themanipulation base of claim 12 wherein said electromechanical device ofsaid second drive system comprises a motor and one of a motor-drivenball screw and a motor-driven lead screw.
 14. The manipulation base ofclaim 12 wherein and said second drive system further comprises a drivenmember configured to operatively engage said second drive interface ofsaid cartridge and to be driven by electromechanical device.
 15. Themanipulation base of claim 14 wherein said drive system furthercomprises a force sensor, said force sensor configured for mechanicallyisolated sensing of the force applied by said second drive system ontosaid second drive interface
 16. The manipulation base of claim 15,wherein said driven member of said second drive system is coupled tosaid electromechanical device by said force sensor.
 17. The manipulationbase of claim 15, wherein said force sensor comprises one of a straingauge and a motor current sensor.
 18. The manipulation base of claim 14wherein said driven member is a drive fork.
 19. The manipulation base ofclaim 14 wherein said driven member comprises a roller disposed therein,said roller configured to operatively engage said second drive interfaceof said cartridge to facilitate rotation of said second drive interface.20. The manipulation base of claim 14 further comprising a bearing blockassociated with said driven member and a bearing rail, said bearingblock configured to travel along said bearing rail as said driven memberis driven by said electromechanical device.
 21. The manipulation base ofclaim 11 further comprising a commutator mounted on said mounting plate,said commutator having a first electrical connector configured to beelectrically connected to an electrical port of said cartridge tothereby electrically connect said commutator to at least one sensor ofsaid elongate medical device electrically connected to said electricalport, said commutator further having a second electrical connectorconfigured for coupling with a complementary electrical connector of anelectrical cable.
 22. The manipulation base of claim 11 wherein saidrotary actuator comprises a motor, and said drive system furthercomprises one of a motor-driven friction interface and a motor-drivengear arrangement.
 23. A drive assembly for use in a roboticallycontrolled medical device guidance system, comprising: a medical devicecartridge including an outer housing and a rotatable medical deviceassembly disposed within said outer housing, said rotatable medicaldevice assembly comprising: an elongate medical device having a proximalend and a distal end; a housing having a first end, a second end, and alongitudinal axis extending therethrough, wherein said proximal end ofsaid elongate medical device is disposed within said housing and saidhousing further comprises an opening disposed in said first end thereofthrough which said elongate medical device extends outwardly from saidhousing in an axial direction relative to said longitudinal axis; and adrive interface coupled with said housing of said rotatable medicaldevice assembly; and a manipulation base, said manipulation basecomprising a mounting plate onto which said medical device cartridge isremovably attached, and a drive system mounted to said mounting plate,wherein said drive system comprises a rotary actuator and is configuredto operatively engage said drive interface of said cartridge and toimpart rotational movement onto said rotatable medical device assemblythrough said drive interface.
 24. The assembly of claim 23 furthercomprising a sterile barrier disposed between said cartridge and saidmanipulation base.
 25. The assembly of claim 23 wherein: said cartridgehas an electrical port disposed in said housing of said rotatablemedical device assembly, said electrical port having a first endconfigured to be electrically coupled with a lead wire of a sensorassociated with said elongate medical device, and a second end disposedexternal to said housing; and said manipulation base comprises acommutator mounted on said mounting plate thereof proximate saidcartridge, said commutator having a first electrical connectorelectrically coupled to said second end of said electrical port of saidcartridge, and a second electrical connector configured for couplingwith a complementary electrical connector of an electrical cable.
 26. Arotatable medical device assembly for use in a medical device cartridgeof a robotically controlled medical device guidance system, comprising:an elongate medical device having a proximal end and a distal end; ahousing having a first end, a second end, and a longitudinal axisextending therethrough, wherein said proximal end of said elongatemedical device is disposed within said housing and said housing furthercomprises an opening disposed in said first end thereof through whichsaid elongate medical device extends outwardly from said housing in anaxial direction relative to said longitudinal axis; and a driveinterface coupled with said housing and configured to be operativelyengaged with a drive system of a manipulation base to impart rotationalmovement onto said rotatable medical device assembly about saidlongitudinal axis of said housing.
 27. The assembly of claim 26 furthercomprising an anchor member disposed within said housing and rigidlycoupled with said proximal end of said elongate medical device.
 28. Theassembly of claim 26 further comprising an electrical port disposed insaid housing, said port having a first end and a second end, said firstend configured to be electrically coupled with a lead wire of a sensorassociated with said elongate medical device, said second end disposedexternal to said housing and configured to be electrically coupled witha complementary electrical connector.
 29. The assembly of claim 26,wherein said drive interface is a first drive interface configured to beoperatively engaged with a first drive system of said manipulation base,and said elongated medical device comprises at least one steering wire,said assembly further comprising: a control member disposed within saidhousing and rigidly coupled with a said steering wire of said elongatemedical device, said control member configured for translationalmovement relative to said longitudinal axis; and a second driveinterface coupled with said control member and configured to beoperatively engaged with a second drive system of said manipulation baseto impart translational movement onto said control member.
 30. Theassembly of claim 29 wherein said housing includes an axially extendingslot therein, and said control member includes a pin extending therefromin a radial direction relative to said longitudinal axis of saidhousing, and further wherein said pin is disposed and configured fortravel within said slot in an axial direction relative to saidlongitudinal axis, and said second drive interface is coupled with saidpin. 31-32. (canceled)